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Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler is for inhalation use only.
Patients should be made aware that Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler must be used daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone. As an alternative, patients requiring a long acting beta-2-agonist could be titrated to Salmeterol and Fluticasone Propionate Pressurized Inhalation.
CFC Free inhaler given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control. In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly day-time symptoms the dose should be given in the morning.
Patients should be given the strength of Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler containing the appropriate Fluticasone propionate dosage for the severity of their disease.
Note: Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler 25 + 50 micrograms strength is not appropriate in adults and children with severe asthma. Prescribers should be aware that, in patients with asthma, Fluticasone propionate is as effective as other inhaled steroids at approximately half the microgram daily dose. If an individual patient should require dosages outside the recommended regimen, appropriate doses of beta-agonist and/or corticosteroid should be prescribed.
Recommended Doses: Adults and adolescents 12 years and older: Two inhalations of 25 micrograms Salmeterol and 50 micrograms Fluticasone propionate twice daily.
Or, two inhalations of 25 micrograms Salmeterol and 125 micrograms Fluticasone propionate twice daily.
Or, two inhalations of 25 micrograms Salmeterol and 250 micrograms Fluticasone propionate twice daily.
A short term trial of Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential. In these cases, the recommended initial dose is two inhalations of 25 micrograms Salmeterol and 50 micrograms Fluticasone propionate twice daily. Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stopped down to an Inhaled corticosteroid alone. Regular review of patients as treatment Is stopped down is important.
A clear benefit has not been shown as compared to inhaled Fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing. In general inhaled corticosteroids remain the first line treatment for most patients. Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler is not intended for the initial management of mild asthma. Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler 25 micrograms/50 micrograms strength is not appropriate in adults and children with severe asthma: it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma.
Children 4 years and older: Two inhalations of 25 micrograms Salmeterol and 50 micrograms Fluticasone propionate twice daily.
The maximum licensed dose of Fluticasone propionate delivered by Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler in children is 100 microgram twice daily. There are no data available for use of Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free Inhaler in children aged under 4 years.
Patients should be instructed in the proper use and care of their inhaler and their technique checked to ensure optimum delivery of the inhaled drug to the lungs.
Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler in patients with hepatic Impairment.
Instructions for Use: Patients should be instructed in the proper use of their inhaler.
During inhalation, the patient should preferably sit or stand. The inhaler has been designed for use in an inverted position.
